Self-sealing shell for inflatable prostheses

ABSTRACT

A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-swellable material distributed therein.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.13/741,093, filed Jan. 14, 2013, which is a divisional of U.S. patentapplication Ser. No. 12/543,795, filed Aug. 19, 2009, now U.S. Pat. No.8,690,943 issued Apr. 8, 2014, which claims priority to U.S. ProvisionalPatent Application No. 61/090,328, filed on Aug. 20, 2008, the entiredisclosure of each of which is incorporated herein by this reference.

FIELD OF THE INVENTION

The present invention relates to fluid-filled prosthetic implants and,more particularly, to the construction of a self-sealing shell for aninflatable prosthesis.

BACKGROUND OF THE INVENTION

Implantable prostheses are commonly used to replace or augment bodytissue. In the case of breast cancer, it is sometimes necessary toremove some or all of the mammary gland and surrounding tissue whichcreates a void that can be filled with a fluid-filled implantableprosthesis. The implant serves to support surrounding tissue and tomaintain the appearance of the body. The restoration of the normalappearance of the body has an extremely beneficial psychological effecton post-operative patients, alleviating much of the shock and depressionthat often follows extensive surgical procedures.

Soft implantable prostheses typically include a relatively thin andquite flexible envelope or shell made of silicone elastomer. The shellis filled either with a silicone gel or with a physiologic salinesolution. The filling of the shell may take place before or after theshell is implanted in the patient.

A saline-filled implant includes an outer shell of several layers ofsilicone elastomer having a valve or fill port on one side. Theprosthesis is typically implanted into the breast cavity in an empty oronly partially filled state. The implant is then inflated to its finalsize by means of the valve or fill port. This helps reduce the size ofthe needed incision, and enables a surgeon to adjust and evenmicroadjust the volume of the implant. Unfortunately, the valve or fillport is sometimes noticeable to the touch.

Prior to implantation of a more permanent prosthesis, it is commonpractice to utilize a more temporary implant, for example, what is knownas a “tissue expander” in order to gradually create the space necessaryfor the more permanent prosthesis. Essentially, a tissue expandercomprises an inflatable body, having an inflation valve connectedthereto. The valve may be formed into the inflatable body itself or maybe remotely located and connected to the inflatable body by means of anelongated conduit.

The inflatable body of the tissue expander is placed subcutaneously inthe patient, at the location of where tissue is to be expanded. Theinflation valve, whether on the implant or remote thereto, is alsosubcutaneously positioned or implanted, and is configured to allowgradual introduction of fluid, typically saline, into the inflationbody, by injection with a syringe. After gradual inflation atpre-determined intervals, the skin and subcutaneous tissues overlyingthe expander are consequently caused to expand in response to thepressure exerted upon such tissues by the inflatable body as solution isgradually introduced therein.

After gradual inflation at pre-determined intervals, which may extendover weeks or months, the skin and subcutaneous tissue will expand tothe point where further medical procedures can be performed, such as thepermanent implantation of a prosthesis, plastic and reconstructivesurgery, or for use of the skin and subcutaneous tissue for use in someother part of the body.

During a mastectomy, a surgeon often removes skin as well as breasttissue, leaving the chest tissues flat and tight. To create abreast-shaped space for a reconstructive implant, a tissue expander issometimes used as described above.

In any event, it should be appreciated that locating the fill valve onthe prosthesis or tissue expander requires considerable practitionerskill. Attempts to make products which facilitate this include thedevelopment of various products having structure, for example, embeddedmagnets or a raised ring, for assisting physicians in locating thevalve.

Bark, et al., U.S. Pat. No. 5,074,878, discloses a tissue expander.According to Bark et al., the tissue expander comprises a closed shellstructure having a wall formed of a needle-penetrable material which hasself-sealing characteristics. The shell includes a flowable self-sealinglayer sandwiched between layers of non-flowable elastomeric material.

There still remains a need for better inflatable implant shells.

SUMMARY OF THE INVENTION

The present invention provides inflatable prosthetic implants,components thereof and methods of making same. Advantageously, theimplants include a self-sealing shell, thus eliminating or substantiallyreducing the need for a traditional fill valve. It is to be appreciatedthat the terms “implant” “prosthesis” as used herein are intended toencompass permanent implants, as well as relatively temporary tissueexpanders, and components, for example, shells, of such implantabledevices.

Advantageously, the present invention is relatively simple tomanufacture and straightforward in construction. Many embodiments of thepresent invention can be made using conventional shell manufacturingequipment and using readily commercially available materials. Forexample unlike many previously proposed breast implant shells allegedlyhaving self-sealing attributes, many of the present implants do not needto be formed, molded and/or cured under a specific compression ortension.

In a broad aspect of the invention, a shell for an inflatable implantgenerally comprises a self-sealing layer comprising an elastomercomponent and particles, for example, discontinuous particles, of aswellable material dispersed in the elastomer component. In addition,the shell is structured such that when the shell is substantially dry ordehydrated, the shell is not self-sealable, and when the shell is wet orhas been exposed to or contacted with an aqueous fluid, for example,water, the fluid enters the layer and causes the particles dispersedtherein to swell within the elastomer component. Compressive forcesresulting from the swollen particles within the elastomer componentcause the shell to become self-sealing, for example, with respect to aneedle puncture through the shell.

More specifically, the layer may be comprised of an elastomericcomponent, for example, a biocompatible, silicone-based material, anddiscontinuous, swellable particles dispersed throughout the elastomericcomponent. For example, the shell may comprise a silicone elastomermatrix having hydrogel particles distributed throughout the matrix. Whencontacted with an aqueous fluid, such as water or saline, the layer ispenetrated by the fluid and the fluid is absorbed by the particles,causing the particles to swell or expand. Compressive forces created bythe elastomeric component and the swelled particles dispersed thereincause the layer to become self-sealing, for example, self-sealing to aneedle puncture when such a needle penetrates and is then withdrawn fromthe layer.

The self-sealing surface may be in the form of a patch used to seal ahole or aperture of a breast implant shell. In other embodiments, theself-sealing surface is larger than a conventional patch and mayencompass an entire, or substantially entire, wall of the shell.Advantageously, this allows for relatively easy percutaneous fluidadjustment of the implant that does not require locating accessories orspecial equipment.

In some embodiments, the self-sealing material in accordance with theinvention forms a shell of an inflatable gastric balloon useful fortreatment of obesity.

In a more specific embodiment of the invention, the particles comprisehydrogel particles. In some embodiments, the hydrogel particles aremixed into an uncured, liquid form of the elastomeric component whilethe particles are in a dry or at least partially dehydrated state. Theparticles may comprise a polyethylene glycol, a hydroxyethylcellulose,or another suitable biocompatible hydrogel material, or mixturesthereof.

Preferably, the elastomer component comprises a silicone elastomermaterial that is conventionally used in the construction of flexibleshells for inflatable implants. For example, the elastomer component maycomprise any suitable silicone elastomeric material. Suitable siliconeelastomers include, but are not limited to, homopolymers such aspolydimethylsiloxane or polymethylvinylsiloxane, or copolymers such ascopolymers of diphenylsiloxane and dimethylsiloxane.

The silicone elastomer can be cured by conventional means, for example,by using a polysiloxane crosslinker containing silicone-bonded hydrogenatoms with a vinyl containing siloxane elastomer and a platinumcatalyst.

The present invention further provides an article of material useful asa shell for an inflatable implant, wherein the article is manufacturedby the steps comprising providing hydrogel particles, for example in asubstantially dry state, providing an elastomer material dispersion,mixing the hydrogel particles into the elastomer material dispersion,curing the elastomer material dispersion having the substantially dryhydrogel particles therein to obtain a useful article which has thecharacteristic of being self-sealable, for example, when punctured witha needle, when the article has been contacted with an aqueous fluid, forexample, water or saline.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a cross-sectional view through a self-sealing implantprosthesis of the present invention having a molded-in-place flushpatch;

FIG. 2A is a sectional view through a portion of the wall of theself-sealing implant prosthesis of FIG. 1 prior to implant;

FIG. 2B is a sectional view through a portion of the wall of theself-sealing implant prosthesis of FIG. 1 after implant and absorbanceof an aqueous fluid to cause swelling of particles therein; and

FIGS. 3A-3B show needle puncture of and subsequent withdrawal from theimplant prosthesis wall of FIG. 1 illustrating a self-sealing characterof the wall.

DETAILED DESCRIPTION

The present invention provides a fluid-filled inflatable prosthesisformed with a flexible outer shell having a wall that is at least partlyconstructed of a polymer matrix and a plurality of particles of materialevenly or randomly distributed in the matrix. The shell wall self-sealsaround needle punctures.

The present invention is especially useful for soft fluid-filledimplants, for example, but not limited to, implants useful in breastreconstruction or breast augmentation procedures.

FIG. 1 illustrates an exemplary cross-section of a prosthesis, forexample, a fluid-filled breast implant 20 of the present invention. Theimplant 20 includes an elastomer shell 22 having an anatomicalconfiguration, in this case, a configuration suitable for augmenting orreconstructing a human breast. The shell 22 is shown filled with a fluidsuch as physiologic saline 30. A patch 24 covers an aperture left overfrom a dipping or rotational molding process used to form the shell 22.

FIG. 2A shows a wall 28 of the shell 22 prior to the shell 22 beingfilled with saline. The wall 28 may make up the entire shell 22 or maymake up only a portion of the shell 22. The wall 28 comprises anelastomer component 32 and discontinuous particles 34 of a swellablematerial dispersed in the elastomer component 32. Turning now to FIG.2B, the wall 28 is shown after having been contacted with an aqueousfluid, for example, water. When the wall 28 is contacted with an aqueousfluid, the particles 34 of swellable material enlarge such that the wall28 becomes self-sealing to a needle puncture.

In accordance with one aspect of the invention, the wall 28 has thecharacteristic of being not self sealing when it is in a dry state (FIG.2A), but nearly substantially entirely self-sealing when in the wetstate (FIG. 2B), that is, after it has been contacted with water orother suitable aqueous medium. Contact with an aqueous fluid may beaccomplished by exposing the shell or wall of said shell to liquidwater, steam or humid environment.

The shell wall 22 includes a polymer matrix 32 and a plurality ofparticles 34 substantially uniformly or randomly distributed therein. Itcan be said that the particles 34, in a sense, are entrapped in thepolymeric elastomer component 32, or occupy enclosed spaces within theelastomeric material which forms a matrix around the particles.

The polymer matrix 32 may be a silicone elastomer such as a dimethylsilicone elastomer. The polymer matrix 32 may comprise a substantiallyhomogeneous dimethyl-diphenyl silicone elastomer. One especiallyadvantageous composition useful in the present invention is described inSchuessler, et al., U.S. application Ser. No. 12/179,340, filed Jul. 24,2008, albeit for gel-filled prostheses, the disclosure of which isincorporated herein in its entirety by this specific reference.

In one aspect of the present invention, the shell wall 22 comprises acolloid of the matrix 32 having the swellable particles 34 therein. Acolloid in this sense generally means a material made up of a system ofparticles dispersed in a continuous medium. The size of the particlescan vary, and they remain dispersed indefinitely in the medium. Incontrast with some definitions of colloid, in accordance with thepresent invention the linear dimensions of the particles need not bewithin a specified range. For purposes of the present invention, theswellable particles may be in the form of a solid or a liquid, as longas they do not mix or otherwise dissolve into the surrounding matrixmaterial 32.

In one embodiment, the shell wall 22 is formed by dispersing solidparticles 34 in a liquid matrix 32, which is then cured. In anotherembodiment, the shell wall 22 is formed by creating an emulsion ofliquid particles 34 immiscible in a liquid matrix 32, which is thencured. The elastomeric component of the shell wall 22 may be anon-water-swellable silicone elastomer within which water-swellablesolid or liquid particles are entrapped.

In one aspect of the invention, the particles 34 are a water-swellablematerial which swells upon contact with an aqueous fluid. For instance,the material of the particles 34 may be a hydrogel material, orpolyethylene glycol (PEG) material. The particles 34 may be in liquid orsolid form, as mentioned, and the same substance may be provided ineither phase.

In some embodiments, the water swellable particles 34 have a molecularweight of between about 200 and about 10,000 Daltons. In someembodiments, the particles 34 make up about 2% by weight of theparticle/matrix composition. In some embodiments, the particles 34 makeup at least about 2% by weight of the particle/matrix composition, up toabout 40% by weight of the composition. In some embodiments, theparticles make up about 25% by weight of the composition.

The combination of the polymer matrix 32 and particle 34 wallconstruction self-seals around needle punctures once the material hasbeen exposed to or contacted with an aqueous fluid such as water,saline, body fluid, or other biocompatible liquid. Once contacted withan aqueous fluid, the wall 22 allows the fluid to enter the elastomermatrix and upon contacting the particles, the particles 34 swell andexpand as shown in FIG. 2B. Although not wishing to be bound by anyspecific theory of operation, it is believed that the swelling of theparticles 34 creates compressive forces in the wall which makes theshell self-sealing to puncture, for example, with a standard gaugeneedle.

Various processes are known for forming the flexible implant shells forimplantable prostheses and tissue expanders of the present invention. Ineach, a plurality of the particles 34 of the water-swellable materialare distributed in a quantity of the liquid polymer matrix 32 to form acolloid. Again, the particles 34 may be in solid or liquid form. Thecolloid is then solidified to form a portion of the shell wall 22. Thecolloid may be formed as a sheet material and used for a patch of anotherwise non-self-sealing shell, or may be used as the entire shell,including the patch. In the former case, the colloid first solidifiesand is then formed into part of the shell, while in the latter case, thecolloid simultaneously solidifies and forms the shell. The shell is thenexposed to an aqueous fluid (such as by filling with saline) such thatthe particles swell and the colloidal portion of the shell wall iscapable of self-sealing around needle punctures. In one process, asuitably shaped mandrel may be dipped one or more times into adispersion of the polymer matrix with distributed water-swellableparticles. Each time the mandrel is withdrawn from the dispersion andthe excess is allowed to drain from the mandrel. After the excessdispersion has drained from the mandrel at least a portion of solventwithin the dispersion is allowed to evaporate to stabilize the siliconeelastomer coating. Also, curing may take place between dippings. Theprocess is then repeated several times until a shell of the desiredthickness is formed. Furthermore, the layered structure of currentsilicone elastomer shells can be made by sequentially dipping themandrel in different dispersions.

In one embodiment, the invention comprises forming an elastomer shell 22within an injection or rotational molding system. A liquid quantity ofthe polymer matrix with distributed water-swellable particles isintroduced within a mold cavity, which then may be rotated aboutmultiple axes. The liquid evenly coats the inside of the mold cavity asit rotates, and heat is applied to cure the liquid to a more solid form.One exemplary rotational molding system disclosed in U.S. Pat. No.7,165,964 to Schuessler, the entire disclosure of which is incorporatedherein, incorporates a vent system to remove volatilized solvents, and amold liner to eliminate a mold seam. The patch 24 may be molded in placewithin the mold cavity, as disclosed in U.S. patent application Ser. No.12/431,070 filed Apr. 28, 2009, and having common inventor and commonassignee herewith, the entire disclosure of which is incorporated hereinby this specific reference.

In one embodiment, the implant 20 is a breast implant or a tissueexpander for a breast. The implant 20 may be inserted into a breastcavity in an empty or partially-filled state. Introducing an implantthat is not completely filled naturally reduces the required size of theincision, which is beneficial as it leaves a smaller scar. Once in placethe surgeon fills the hollow interior of the shell 22 with anappropriate fluid 30 such as physiologic saline via a needle.Advantageously, the entire shell wall, and preferably also the patch 24,is formed of the self-sealing construction and thus there is littletrouble locating an appropriate injection site.

In another embodiment, the implant 20 is an inflatable member of agastric balloon useful for treatment of obesity.

FIG. 3A illustrates a needle 40 attached to a syringe 42 penetrating alocation in the shell wall 22. An additional quantity of the fluid 30 isthen injected into the shell 22 to either incrementally expand theshell, as with tissue expanders, or fill the shell to a predeterminedvolume. The final volume varies depending on the desired outcome.Additional fluid adjustments may be desired to fine tune the finalvolume. In that case, a needle is again used to either remove or addfluid.

FIG. 3B shows the shell wall 22 after removal of the needle 40. Theswelled particles 34 tend to migrate into the puncture created by theneedle 40, and form a seal 44 in the puncture. Multiple punctures atdifferent locations may be made in the shell 22, all of which seal as inFIG. 3B. The advantage of having the entire shell 22 available forinjection will be obvious to those of skill in the art.

As mentioned above, the entire shell 22 of the inflatable prosthesis maycomprise a single layer of the matrix 32 and particles 34 around theentire shell. Alternatively, however, just a portion of the shell 22,such as an anterior face, may include the self-sealing characteristic inaccordance with the invention.

The present invention further provides methods of making an implantablesoft prosthesis. The methods generally comprise the steps of providing aliquid polymer matrix such as a silicone elastomer in a flowable formand distributing particles of a water-swellable material in the polymermatrix to form a fluid elastomer/particle mixture, for example, acolloid. While in a fluid state, the mixture is formed into a membraneor layer which, when solidified, can be used to form at least a part ofa shell wall for an inflatable prosthesis. In order to cause theprosthesis to become self-sealing as described and shown elsewhereherein, the wall is contacted with or exposed to an aqueous fluid.

In one embodiment, the region of the shell having the self-sealingcolloid of the matrix 32 and particles 34 is approximately ½ or more ofthe surface area of the entire shell. Still further, a fill patch over amanufacturing aperture in the shell may be the only portion of theimplant which is self-sealing in accordance with the invention.

EXAMPLE

A silicone elastomer dispersion (polydimethyl siloxane dispersed in axylene solvent such as NuSil MED-6640) at approximately 1000 cps ismixed with polyethylene glycol (8000 MW) powder in a ratio of about 10%by weight of silicone solids.

This mixture is dip cast over a mandrel in the desired shape of theshell. The mixture is dipped several times to achieve a thickness of0.050″ on the mandrel surface after air drying and removal of thesolvent. The shell is cured at about 121 C for about 90 minutes. Theshell is removed from the mandrel. After being contacted with water, theshell is self sealing to a needle puncture.

It is contemplated that the self sealing materials of the presentinvention may be formed into very thin laminates which are applied in alayered fashion to traditional silicone elastomeric shells. It isfurther contemplated that the self-sealing material may make up one ormore layers of a shell which are sandwiched between layers of siliconeelastomer such that the self sealing layer is spaced apart from innerand outer surfaces of the shell wall.

Although the invention has been described and illustrated with a certaindegree of particularity, it is understood that the present disclosurehas been made only by way of example, and that numerous changes in thecombination and arrangement of parts can be resorted to by those skilledin the art without departing from the scope of the invention, ashereinafter claimed.

What is claimed is:
 1. A method of making an implantable and inflatableprosthesis, the method comprising the steps of: providing a curablepolymer-based liquid; distributing a plurality of solid, water-swellableparticles in the liquid to form a fluid mixture comprising the liquidpolymer and the solid, water-swellable particles; solidifying themixture to form a matrix of the polymer having the solid,water-swellable particles occupying enclosed spaces in the matrix; andforming the mixture into a wall of an inflatable prosthesis comprisingthe matrix and enclosed particles, wherein, when the wall is contactedwith an aqueous fluid, the water-swellable particles expand and the wallbecomes self-sealing to a needle puncture.
 2. The method of claim 1wherein the wall is not self-sealing when it is in a dry state.
 3. Themethod of claim 1 wherein the water-swellable particles make up betweenabout 2% to about 40% by weight of the mixture.
 4. The method of claim 1wherein the water-swellable particles make up about 25% by weight of themixture.
 5. The method of claim 1 wherein the water-swellable particlesare a hydrogel or polyethylene glycol (PEG) material.
 6. The method ofclaim 5 wherein the water-swellable particles have a molecular weight ofbetween about 200 and about 10,000 Daltons.
 7. The method of claim 1wherein the forming is conducted by rotational molding.
 8. The method ofclaim 1 wherein the prosthesis configured to be inserted into a breastcavity in an empty or partially-filled state before being filled withphysiological saline via a needle, the empty or partially-filled statereducing a required size of an incision.
 9. The method of claim 1wherein the prosthesis is configured to be used as an inflatable memberof a gastric balloon useful for treatment of obesity.
 10. The method ofclaim 1 wherein the prosthesis comprises a single layer of the matrixaround an entirety of the prosthesis.
 11. A method of making animplantable soft prosthesis, the method comprising: providing a liquidpolymer matrix; distributing a plurality of particles of awater-swellable material in the polymer matrix to form a colloid;solidifying the colloid into a solid matrix of the polymer entrappingthe particles; forming the colloid into a wall of a shell comprising thesolidified matrix and entrapped particles for an inflatable prosthesis;and contacting the wall with an aqueous fluid such that the particlesswell and the wall becomes capable of self-sealing around a needlepuncture.
 12. The method of claim 11 wherein the wall is notself-sealing when it is in a dry state.
 13. The method of claim 11wherein the water-swellable particles make up between about 2% to about40% by weight of the colloid.
 14. The method of claim 11 wherein thewater-swellable particles make up about 25% by weight of the colloid.15. The method of claim 11 wherein the water-swellable particles are ahydrogel or polyethylene glycol (PEG) material.
 16. The method of claim15 wherein the water-swellable particles have a molecular weight ofbetween about 200 and about 10,000 Daltons.
 17. The method of claim 11wherein the forming is conducted by rotational molding.
 18. The methodof claim 11 wherein the prosthesis is configured to be inserted into abreast cavity in an empty or partially-filled state before being filledwith physiological saline via a needle, the empty or partially-filledstate reducing a required size of an incision.
 19. The method of claim11 wherein the prosthesis is configured to be used as an inflatablemember of a gastric balloon useful for treatment of obesity.
 20. Themethod of claim 11 wherein the prosthesis comprises a single layer ofthe matrix around an entirety of the prosthesis.